REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue

Ovarian Cancer Clinical Trial

Official title:

REVITALIZE: A Telehealth Intervention for Women With Advanced Ovarian Cancer and PARP Inhibitor-Related Fatigue

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04525183
• Other study ID #: 20-285
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: December 28, 2023

Study information

• Verified date: September 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is testing whether a 6 week skills-based telehealth intervention can help ovarian cancer patients experiencing PARP inhibitor-related fatigue reduce the impact of fatigue on their daily life and activities.

Description:

This is a two-arm, multicenter pilot randomized controlled trial to compare the feasibility, acceptability, and preliminary efficacy of REVITALIZE, a 6-week Acceptance and Commitment Therapy (ACT) telehealth intervention vs. enhanced usual care (EUC) in fatigued patients with ovarian cancer on maintenance PARPi.

The intervention is called REVITALIZE, and it is a structured, skills-based intervention for providing support, knowledge, and skills for coping with fatigue. This type of intervention has been used in other studies to treat symptoms such as pain, migraines, or worry. This research is being done to develop this program at the Dana-Farber Cancer Institute and the University of Pennsylvania's Abramson Cancer Center, and to get patient feedback on the telehealth intervention to improve it for a future study. The study is also making a preliminary determinations as to whether REVITALIZE does improve psychological flexibility and fatigue-related interference and reduce fatigue, psychological distress, and fear of cancer recurrence, while improving overall quality of life (QOL).

The study will pre-pilot the REVITALIZE intervention in up to 5 patients at the Dana-Farber Cancer Institute (DFCI). This run-in phase serves to test and refine the newly developed 6-week ACT intervention in a smaller sample size prior to initiating the randomized control trial (RCT) portion of the study. After the ACT intervention has been tested and refined, the study will enroll and randomize 40 fatigued patients with advanced ovarian cancer on maintenance PARPi at Dana-Farber Cancer Institute and the Abramson Cancer Center at the University of Pennsylvania.

Participants will be randomized to receive either a 6-week ACT intervention or enhanced usual care (educational materials). The study anticipates enrolling approximately 20 patients at each site, and 20 patients will be enrolled to each study arm.

It is expected participants will remain in the study for the duration of the intervention and follow-up assessments, which is approximately 3 months.

The Funding Organization for this study is the National Comprehensive Cancer Network (NCCN) and the Research Funding Provider is AstraZeneca.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: December 28, 2023
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women =18 years of age who have been diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

• Receiving PARPI inhibitors for = 2 months.

• Able to read/speak English.

• Have an Eastern Oncology Group (ECOG) performance of 0-2.

• Report moderate-severe fatigue in the past week (average score =4 on a Fatigue Symptom Inventory scale of 0-10)

Exclusion Criteria:

• Patients with an untreated clinical condition or comorbid illness (e.g. anemia, hypothyroidism) that could explain their fatigue.

• Patients with chronic severe fatigue that pre-dates their use of PARPi.

• The following special populations will be excluded from this research:

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Pregnant women

• Prisoners

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Coping Behavior
• Coping Skills
• Fatigue
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Behavioral:
• Enhanced Usual Care (EOC)
Educational materials
• REVITALIZE ACT Intervention
Six 60-75 minute telehealth sessions approximately once a week for 6-8 weeks

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	AstraZeneca, National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment Rate	Feasibility will be defined as =50% approach-to-enrollment rate of participants eligible participants and =70% completion of 3-month outcome assessments.	Baseline to 12-weeks
Primary	Retention Rate	Acceptability will be defined as =20% of participants reporting high study burden and =20% withdrawing from the study.	12 weeks
Primary	Fatigue Change	Changes in fatigue will be measured using the Fatigue Symptom Inventory scale, a 14-item, 11-point rating scale developed to assess subjective fatigue, in which higher scores indicate greater fatigue.	Change in fatigue from baseline to 8 weeks and baseline to 12 weeks
Secondary	Emotional Distress	Measured by Generalized Anxiety Disorder 7 (GAD-7) scale, a 7-item measure assessing anxiety severity on a 4-point scale (0 = not at all, to 3 = nearly every day). GAD-7 total score for the seven items ranges from 0 to 21. Higher scores indicate more moderate to severe anxiety.	Change in emotional distress from baseline to 8 weeks and baseline to 12 weeks
Secondary	Emotional Distress	Measured by the Patient Health Questionnaire-8 (PHQ-8) scale, an 8-item measure assessing depression on a 4-point Likert scale (0 = not at all, to 3 = nearly every day). Higher scores indicate more severe depression.	Change in emotional distress from baseline to 8 weeks and baseline to 12 weeks
Secondary	Fear of Cancer Recurrence (FCRI),	Measured by the 42-item Fear of Cancer Recurrence Inventory (FCRI) scale, which evaluates 7 aspects associated with FCR: 1) triggers, 2) severity, 3) psychological distress), 4) functioning impairments, 5) insight, 6) reassurance, and 7) coping strategies.; Each item is rated on a Likert scale ranging from 0 ('not at all' or 'never) to 4 ('a great deal' or 'all the time'). A total score can be obtained for each subscale, and for the total scale by summing item ratings. Higher scores indicate higher levels of FCR.	Baseline to 8- and 12-weeks
Secondary	Physical well-being	Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale.	Baseline to 8- and 12-weeks
Secondary	Social/family well-being	Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O, scale. Items scored on a 5-point Likert Scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Scores range for each subscale. Higher scores indicate better QOL. Social/family well-being (score range 0-28).	Baseline to 8- and 12-weeks
Secondary	Emotional well-being	Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale. Items scored on a 5-point Likert Scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Scores range for each subscale. Higher scores indicate better QOL. Emotional well-being (score range 0-28).	Baseline to 8- and 12-weeks
Secondary	Functional well-being	Measured by the Functional Assessment of Cancer Therapy-Ovarian Cancer FACT-O scale. Items scored on a 5-point Likert Scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, 4 = very much). Scores range for each subscale. Higher scores indicate better QOL. Functional well-being (score range 0-28).	Baseline to 8- and 12-weeks